Wireless Monitoring in Obstructive Sleep Apnea Management in Military Veterans: 2 Site Pilot Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by VA Connecticut Healthcare System
Sponsor:
Information provided by (Responsible Party):
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT01678560
First received: August 30, 2012
Last updated: March 25, 2013
Last verified: September 2012
  Purpose

Obstructive sleep apnea (OSA) among Veterans is a condition that imparts a great burden to the patient in terms of serious co-morbidities and results in a great cost to the VA Health Care System to treat the co-morbidities, which include heart disease, stroke and neuropsychiatric disorders. Positive airway pressure (PAP) is used to treat sleep apnea and studies have shown a poor adherence to treatment. The investigators hypothesize that using wireless technology will lead to early detection of problems of treatment use and will translate into early remedial action which will improve the use and effectiveness of treatment, and markedly reduce cost to the VA system. The investigators will compare two technologies; storing the data on secure digital cards to follow the patient versus using secure wireless technology to gather the data, a cloud system to store the data, and staff that would be notified in the event of anomalies in treatment use or effectiveness.


Condition Intervention
Obstructive Sleep Apnea
Device: Secure digital (SD) card monitoring
Device: Wireless monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Wireless Monitoring in Obstructive Sleep Apnea Management in Military Veterans: 2 Site Pilot Study

Resource links provided by NLM:


Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • Postive airway pressure treatment adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mean PAP use being > 4 hours per night for greater than 70% of nights.


Secondary Outcome Measures:
  • PAP treatment efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluate the effect active continuous monitoring among patients with sleep apnea on mean nightly residual respiratory disturbance index (RDI), Epworth Sleepiness Scale, Sleep Apnea Quality of Life Index (SAQLI) and Functional Outcomes Of Sleep Questionnaire. (FOSQ)


Other Outcome Measures:
  • Treatment costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compare total costs to patients (sleep clinic visits, travel time, work days missed) and the VA system (travel by homecare providers, sleep clinic visits, supplies) of delivery of OSA management at 30 days, 90 days, 180 days and 1 year between patients receiving conventional CPAP management or active continuous wireless monitoring.


Estimated Enrollment: 220
Study Start Date: April 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Secure digital (SD) card Monitoring
These patients will be monitored using secure digital (SD) cards as the method to obtain adherence and efficacy data.
Device: Secure digital (SD) card monitoring
Experimental: Wireless management
These patients will be monitored using wireless modems as the method to obtain adherence and efficacy data.
Device: Wireless monitoring

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed OSA patients
  • RDI 15 or greater
  • Prescribed CPAP therapy
  • Able to comply with treatment and understand treatment instructions

Exclusion Criteria:

  • Not able to understand study requirements
  • Significant cardiorespiratory disease (e.g. COPD, severe CHF)
  • Clinical instability at time of apnea diagnosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678560

Locations
United States, California
VA San Diego Healthcare System Not yet recruiting
San Diego, California, United States, 92161
Contact: Carl Stepnowsky, PhD       cstepnowsky@ucsd.edu   
Contact: Tania Zamora       tania.zamora@va.gov   
Principal Investigator: Carl Stepnowsky, PhD         
United States, Connecticut
VA Connecticut Health System Not yet recruiting
West Haven, Connecticut, United States, 06516
Contact: Meir Kryger, MD       meir.kryger@yale.edu   
Contact: Klar Yaggi, MD       henry.yaggi@yale.edu   
Principal Investigator: Meir Kryger, MD         
Sponsors and Collaborators
VA Connecticut Healthcare System
Investigators
Principal Investigator: Meir Kryger, MD VA Connecticut Healthcare System
Principal Investigator: Carl Stepnowsky, PhD San Diego Veterans Healthcare System
  More Information

No publications provided

Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT01678560     History of Changes
Other Study ID Numbers: 01648
Study First Received: August 30, 2012
Last Updated: March 25, 2013
Health Authority: United States: Federal Government

Keywords provided by VA Connecticut Healthcare System:
Obstructive sleep apnea PAP adherence efficacy economics

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 31, 2014